Drug Profile
Macitentan/tadalafil - Actelion Pharmaceuticals
Alternative Names: OPSYNVI; Tadalafil /Macitentan-ActelionLatest Information Update: 27 Mar 2024
Price :
$50
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At a glance
- Originator Actelion Pharmaceuticals
- Class Antifibrotics; Antihypertensives; Antineoplastics; Benzodioxoles; Bromobenzenes; Carbolines; Cardiovascular therapies; Erectile dysfunction therapies; Indoles; Pyrimidines; Skin disorder therapies; Small molecules; Sulfonamides
- Mechanism of Action Endothelin A receptor antagonists; Endothelin B receptor antagonists; Type 5 cyclic nucleotide phosphodiesterase inhibitors
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
Highest Development Phases
- Registered Pulmonary arterial hypertension
- Phase III Pulmonary hypertension
Most Recent Events
- 22 Mar 2024 Registered for Pulmonary arterial hypertension (In adults) in USA (PO)
- 22 Mar 2024 Macitentan/tadalafil label has a boxed warning stating the risk of embryo-fetal toxicity
- 25 Aug 2023 Efficacy and adverse event data from a phase III trial in Pulmonary arterial hypertension presented at the ESC Congress 2023 - Annual Congress of the European Society of Cardiology (ESC-Card-2023)